Our team will bring their expertise and specialized skill sets to your project. We offer a full range of services across a variety of therapeutic areas and guarantee responsiveness and open communication throughout every step.
Our project managers take ownership of their projects and serve as a single point of contact and liaison between the sponsor, sites and vendors. The depth and responsiveness of our project management team is a core strength of the TCTM team, with all of our project managers having at least 10 years of clinical research experience. This experience is a key component to TCTM having completed all of our studies either early or on time.
The depth and responsiveness of our project management team is a core strength of the TCTM team.
Adhering to our streamline process allows us to meet enrollment commitments for your study.
We identify the best sites through in-depth research and feasibility to determine the best fit for your project.
Once all sites have been selected, we launch a study efficiently by streamlining our processes. We are quick and responsive, and able to navigate through the study start-up phase with finesse.
Finally, we enroll patients while focusing on maintaining quality and communication. Our patient recruitment expertise is significant to helping us maintain our enrollment track record.
Our monitors are well-trained and focused on early identification and rapid resolution of issues. Our monitoring services include comprehensive risk-based monitoring plans customized to meet your clinical trial design, support for 100% source document verification or risk-based monitoring strategies, immediate attention and resolution to issues of protocol noncompliance, remote monitoring, centralized monitoring, site initiation, interim and close-out visits along with on-going formal training programs.
Our data management team will work closely with your study personnel and the investigator sites to produce audit-ready datasets under effective data governance, which will be locked on or before the agreed-upon date. We employ a philosophy of total quality management to increase our productivity and decrease our error rates on each and every project as we strive to continually increase our value to our clients.
Our medical writing team has extensive experience in protocol development, informed consent, PK/PD report, clinical study report, abstracts, IRB approved patient facing materials, posters, regulatory submissions, and investigator brochure development.
Our creative approach to patient recruitment has led us to consistently meet or exceed enrollment timelines. We work closely with the sites to determine the best recruitment plan for their location, as well as create custom nationwide study campaigns.
TCTM will tailor the recruitment plan most effective for your study and guarantee cost-effective, measurable results.
TCTM has a multifaceted approach to patient recruitment and retention along with a proven track record of success. In addition to completing enrollment for studies early or on time, we maintain a retention rate of 93% for all completed studies.
Our project team implements a customized retention plan at the start of each study, with a heavy emphasis on addressing the needs of each site. Throughout the study, we consistently monitor and track enrollment results, allowing us to identify any potential retention issues early on.
Our clinical quality management team will ensure your study withstands regulatory scrutiny and adheres to FDA Good Clinical Practice compliance guidelines from study inception to database lock. Our team operates with a sense of urgency to proactively identify early quality events and provide a prompt resolution, resulting in the sustained momentum of your study to meet targeted deadlines.
The services we provide include: trial specific audits, root cause analysis, corrective and preventive action plans, development of risk management and quality improvement plans, quality documentation reports, serious adverse event coordination, validation of quality process, central study TMF audits and determining system requirements for your study.